Job Description Summary # Job Description Summary This person will assure departmental compliance with ISO and FDA requirements through supporting internal and external audits, perform ad hoc and standard analytics of customer complaints, participation on teams and assigned project support, process improvements, review of medical device complaint files for potential reportability, and coordination and resolution of CAPAs. Additionally the person will perform inquiry and analysis of CRM Dispensing device transactions to provide actionable data to Quality Management including the evaluation of complaints for potential adverse events. Responsibilities: + Develops and maintains efficient methods for regularly reporting to management the current status of product quality with respect to Quality objectives and goals. + Responsible for reviewing customer complaints received for Medical Device Reports (MDRs), FDA and ISO requirements. + Able to manage the end to end process of customer complaints including review and maintenance of complaint files for validity and assures compliance with policies and procedures. + Work with Regional Complaint Centers to resolve and address complaint handling issues. + Utilization of database systems used to process complaints, create and measure Quality metrics and electronic MDR reports. + Provide internal guidance and education regarding customer complaint processing, MDRs, and regulatory compliance. + Monitoring and trending quality indicators for distributed components/products and provides quality metrics as required to generate quality system improvements. + Participate in continuous improvement efforts specific to complaint data and analytics. + Effectively creates, customizes and delivers presentations, both in person and via remote meeting technologies. + Collaborate with appropriate clinical, technical, and/or regulatory employees to ensure timeliness and compliance with all FDA regulations and standards related to the review of events/complaints for BD products + Comply with the site Quality System Qualifications & Skill Set: + Self-motivated; works independently with minimal supervision. + Takes initiative to establish and meet goals and objectives. + Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations + Exhibit flexibility and adaptability by managing assignments in accordance with project priorities and by altering course of action when and where necessary. + Strong analytical, problem solving, organizational, and planning skills. + Demonstration of good documentation practices. Education & Experience Required: + Bachelor’s degree in relevant field preferred or equivalent combination of education and applicable job experience + Minimum of 1-2 year experience in Quality, Regulatory or Complaint management; or equivalent combination of education and experience. + Working knowledge of QA in a medical device industry. + Familiar with the FDA Title 21 and ISO 13485 requirements preferred. + Must have a strong working knowledge of Microsoft Office applications (Word, Excel, Power Point, OneNote) + Understanding of complaint handling, experience with Salesforce and TrackWise preferred. + Dispensing or Technology Solutions product technology experience a plus. + Experience with Data Visualization tools such as Tableau, QlikView, or Power BI a plus. #LI-OPS Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status. # Primary Work LocationUSA CA - San Diego TC Bldg C&D # Additional Locations # Work Shift Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.